Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI

NCT03081208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 810

Last updated 2019-12-23

No results posted yet for this study

Summary

The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.

Conditions

Interventions

DRUG

Nolasiban 900mg

Nolasiban dispersible tablets for single oral administration

DRUG

Placebo

Placebo dispersible tablets for single oral administration

Sponsors & Collaborators

  • ObsEva SA

    lead INDUSTRY

Principal Investigators

  • ObsEva SA · Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2018-03-21
Completion
2019-02-19

Countries

  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Hungary
  • Poland
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03081208 on ClinicalTrials.gov